1. A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE)
- Author
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Iris W. J. M. van Goor, L.A. Daamen, M.G. Besselink, A.M.E. Bruynzeel, O.R. Busch, G.A. Cirkel, B. Groot Koerkamp, N. Haj Mohammad, H.D. Heerkens, H.W.M. van Laarhoven, G.J. Meijer, J. Nuyttens, H.C. van Santvoort, G. van Tienhoven, H.M. Verkooijen, J.W. Wilmink, I.Q. Molenaar, M.P.W. Intven, Surgery, Radiotherapy, Radiation Oncology, CCA - Cancer Treatment and quality of life, Internal medicine, CCA - Cancer Treatment and Quality of Life, Amsterdam Gastroenterology Endocrinology Metabolism, and Oncology
- Subjects
Isolated local recurrence ,SBRT ,Medicine (miscellaneous) ,PDAC ,Image-guided radiotherapy ,Pancreatic cancer ,Radiosurgery ,Disease recurrence ,Pancreatic Neoplasms ,Pancreatic ductal adenocarcinoma ,SDG 3 - Good Health and Well-being ,Stereotactic body radiation therapy ,Quality of Life ,Humans ,Pituitary Adenylate Cyclase-Activating Polypeptide ,Pharmacology (medical) ,Prospective Studies ,Neoplasm Recurrence, Local ,Retrospective Studies ,Carcinoma, Pancreatic Ductal ,SABR - Abstract
Background Disease recurrence is the main cause of mortality after resection of pancreatic ductal adenocarcinoma (PDAC). In 20–30% of resected patients, isolated local PDAC recurrence occurs. Retrospective studies have suggested that stereotactic body radiation therapy (SBRT) might lead to improved local control in these patients, potentially having a beneficial effect on both survival and quality of life. The “nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy” (ARCADE) will investigate the value of SBRT in addition to standard of care in patients with isolated local PDAC recurrence compared to standard of care alone, regarding both survival and quality of life outcomes. Methods The ARCADE trial is nested within a prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the ‘Trials within Cohorts’ design. All PACAP participants with isolated local PDAC recurrence after primary resection who provided informed consent for being randomized in future studies are eligible. Patients will be randomized for local therapy (5 fractions of 8 Gy SBRT) in addition to standard of care or standard of care alone. In total, 174 patients will be included. The main study endpoint is survival after recurrence. The most important secondary endpoint is quality of life. Discussion It is hypothesized that additional SBRT, compared to standard of care alone, improves survival and quality of life in patients with isolated local recurrence after PDAC resection. Trial registration ClinicalTrials.gov registration NCT04881487. Registered on May 11, 2021.
- Published
- 2022